Impact of Antimalarial Treatment on Measures of T Cell Suppression/Regulation in Healthy Adults From Doneguebougou, Mali

NCT02659566 | Completed

• 2 other identifiers: 99991605116-I-N051
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Malaria is a disease that affects many people in the country of Mali and other parts of Africa. It is caused by germs that are spread by mosquito bites. Malaria may be mild, but can also be serious or can lead to death if not diagnosed and treated promptly. Children younger than 5 years and pregnant women are at highest risk of malaria. Researchers want to better understand how malaria infection suppresses the immune system. They want to compare a group of adults who receive antimalarial treatment to a group that does not receive it. Objective: To investigate the effect of antimalarial treatment at the beginning of the dry season on the immune system and malaria episodes. Eligibility: Healthy adults ages 18-60 who live in the area of Doneguebougou, Mali. Design: Participants will be screened with a physical exam and health questions. If participants are found to be sick at the screening visit, they will get initial care at the study clinic free of charge. They may get referrals for consultation. Participants will be randomly assigned to a group. One group will get an approved antimalarial drug called Coartem . The other will not receive it. Participants in the Coartem group will take the drug for 3 days. All participants will have blood tests. Al participants will be seen about once a month for about 1 year. At each visit, they will be asked how they are feeling and be examined. Blood will be drawn. If participants become sick at any time, they will come to the clinic to be examined.

Conditions

Malaria

Keywords

Markers; Parasitemia; Coartem; Plasmodium; Infection

Outcome Measures

Primary Outcomes (1)

• To measure the percentage of T cells expressing PD-1 during scheduled visits by comparing markers of T cell suppression/regulation in adults (specifically PD-1) who receive or do not receive antimalarial treatment at the beginning of dry season ...

  Twelve months

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A study participant must satisfy the following criteria to be enrolled in this study:
• Provide individual informed consent
• Adult between ages of 18 and 60
• Willingness to have blood samples stored for future research
• Known resident of Ouelessebougou or surrounding area

You may not qualify if:

• A subject will be excluded from participating in this trial if any one of the following criteria is fulfilled:
• Known to be pregnant (by history) or positive pregnancy test
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, psychiatric, or renal disease by history and/or physical examination that may impact the subject s overall health and immune system
• Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol
• Use of chronic (greater than or equal to14 days) oral or intravenous corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \>10 mg/day) or immunosuppressive drugs within 30 days of Study Day 0
• Receipt of Coartem within less than 14 days from Study Day 0
• Known allergies or contraindications (such as significant cardiac disease prolonged QTc \>450 ms; currently taking medications that may prolong your QTc; serious side effects from Coartem in the past) to study treatment (Coartem \[artemether/lumefantrine\])
• Receipt of investigational malaria vaccine within the last 5 years
• Enrollment in another investigational trial during the study period (participating in screening for other investigational trials is permitted)
• Tested positive for HIV or Hepatitis B or Hepatitis C.
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the subject unable to comply with the protocol

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Ouelessebougou Clinical Research Center

Bamako, Mali

Location

Related Publications (3)

• Cunnington AJ, Riley EM. Suppression of vaccine responses by malaria: insignificant or overlooked? Expert Rev Vaccines. 2010 Apr;9(4):409-29. doi: 10.1586/erv.10.16.

  PMID: 20370551 BACKGROUND

• Illingworth J, Butler NS, Roetynck S, Mwacharo J, Pierce SK, Bejon P, Crompton PD, Marsh K, Ndungu FM. Chronic exposure to Plasmodium falciparum is associated with phenotypic evidence of B and T cell exhaustion. J Immunol. 2013 Feb 1;190(3):1038-47. doi: 10.4049/jimmunol.1202438. Epub 2012 Dec 21.

  PMID: 23264654 BACKGROUND

• Moormann AM, Snider CJ, Chelimo K. The company malaria keeps: how co-infection with Epstein-Barr virus leads to endemic Burkitt lymphoma. Curr Opin Infect Dis. 2011 Oct;24(5):435-41. doi: 10.1097/QCO.0b013e328349ac4f.

  PMID: 21885920 BACKGROUND

MeSH Terms

Conditions

Malaria; Parasitemia; Infections

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Mosquito-Borne Diseases; Vector Borne Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michal Fried, Ph.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 20, 2016
• Study Start: January 15, 2016
• Primary Completion: June 12, 2018
• Study Completion: June 12, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06-12

Locations

MA (1)